Meeting of the Secretary's Advisory Committee on Human Research Protections, 6799-6800 [2012-2958]
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Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Notices
Dated: February 7, 2012.
Bernadette B. Wilson,
Senior Program Analyst. Executive
Secretariat.
This Notice Issued February 7, 2012.
[FR Doc. 2012–3175 Filed 2–7–12; 4:15 pm]
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DEPARTMENT OF DEFENSE
GENERAL SERVICES
ADMINISTRATION
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
[OMB Control No. 9000–0142; Docket 2011–
0079; Sequence 19]
Federal Acquisition Regulation;
Submission for OMB Review; Past
Performance Information
Department of Defense (DOD),
General Services Administration (GSA),
and National Aeronautics and Space
Administration (NASA).
ACTION: Notice of request for public
comments regarding an extension to an
existing OMB clearance.
AGENCIES:
Under the provisions of the
Paperwork Reduction Act the
Regulatory Secretariat will be
submitting to the Office of Management
and Budget (OMB) a request to review
and approve an extension of a
previously approved information
collection requirement concerning past
performance information. A notice was
published in the Federal Register at 76
FR 67153, on October 31, 2011. No
comments were received.
Public comments are particularly
invited on: Whether this collection of
information is necessary for the proper
performance of functions of the FAR,
and whether it will have practical
utility; whether our estimate of the
public burden of this collection of
information is accurate, and based on
valid assumptions and methodology;
ways to enhance the quality, utility, and
clarity of the information to be
collected; and ways in which we can
minimize the burden of the collection of
information on those who are to
respond, through the use of appropriate
technological collection techniques or
other forms of information technology.
DATES: Submit comments on or before
March 12, 2012.
ADDRESSES: Submit comments
identified by Information Collection
9000–0142, Past Performance
Information, by any of the following
methods:
• Regulations.gov: https://
www.regulations.gov. Submit comments
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via the Federal eRulemaking portal by
inputting ‘‘Information Collection 9000–
0142, Past Performance Information,’’
under the heading ‘‘Enter Keyword or
ID’’ and selecting ‘‘Search.’’ Select the
link ‘‘Submit a Comment’’ that
corresponds with ‘‘Information
Collection 9000–0142, Past Performance
Information.’’ Follow the instructions
provided at the ‘‘Submit a Comment’’
screen. Please include your name,
company name (if any), and
‘‘Information Collection 9000–0142,
Past Performance Information,’’ on your
attached document.
• Fax: 202–501–4067.
• Mail: General Services
Administration, Regulatory Secretariat
(MVCB), 1275 First Street NE.,
Washington, DC 20417. ATTN: Hada
Flowers/IC 9000–0142, Past
Performance Information.
Instructions: Please submit comments
only and cite Information Collection
9000–0142, Past Performance
Information, in all correspondence
related to this collection. All comments
received will be posted without change
to https://www.regulations.gov, including
any personal and/or business
confidential information provided.
FOR FURTHER INFORMATION CONTACT: Mr.
Curtis E. Glover, Sr., Procurement
Analyst, Acquisition Policy Division, at
GSA (202) 501–1448 or email
Curtis.glover@gsa.gov.
SUPPLEMENTARY INFORMATION:
A. Purpose
Past performance information
regarding a contractor’s actions under
previously awarded contracts is relevant
information for future source selection
purposes.
B. Annual Reporting Burden
Respondents: 150,000.
Responses per Respondent: 4.
Annual Responses: 600,000.
Hours per Response: 2.
Total Burden Hours: 1,200,000.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat (MVCB), 1275
First Street NE., Washington, DC 20417,
telephone (202) 501–4755. Please cite
OMB Control No. 9000–0142, Past
Performance Information, in all
correspondence.
Dated: February 3, 2012.
Laura Auletta,
Director, Office of Governmentwide
Acquisition Policy, Office of Acquisition
Policy, Office of Governmentwide Policy.
[FR Doc. 2012–3050 Filed 2–8–12; 8:45 am]
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6799
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Secretary’s Advisory
Committee on Human Research
Protections
Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary for
Health.
ACTION: Notice.
AGENCY:
Pursuant to Section 10(a) of
the Federal Advisory Committee Act,
U.S.C. Appendix 2, notice is hereby
given that the Secretary’s Advisory
Committee on Human Research
Protections (SACHRP) will hold its
twenty-seventh meeting. The meeting
will be open to the public. Information
about SACHRP and the meeting agenda
will be posted on the SACHRP Web site
at: https://www.dhhs.gov/ohrp/sachrp/
mtgings/.
DATES: The meeting will be held on
Tuesday, February 28, 2012 from 8:30
a.m. until 5 p.m. and Wednesday,
February 29, 2012 from 8:30 a.m. until
5:00 pm.
ADDRESSES: U.S. Department of Health &
Human Services, 200 Independence
Avenue SW., Hubert H. Humphrey
Building, Room 705, Washington, DC
20201.
SUMMARY:
Jerry
Menikoff, M.D., J.D., Director, Office for
Human Research Protections (OHRP), or
Julia Gorey, J.D., Executive Director,
SACHRP; U.S. Department of Health
and Human Services, 1101 Wootton
Parkway, Suite 200, Rockville,
Maryland 20852; 240–453–8141; fax:
240–453–6909; email address:
Julia.Gorey@hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Under the
authority of 42 U.S.C. 217a, Section 222
of the Public Health Service Act, as
amended, SACHRP was established to
provide expert advice and
recommendations to the Secretary of
Health and Human Services and the
Assistant Secretary for Health on issues
and topics pertaining to or associated
with the protection of human research
subjects.
The meeting will open February 28
with remarks from SACHRP Chair Dr.
Barbara Bierer and OHRP Director Dr.
Jerry Menikoff, followed by a summary
report from the Presidential
Commission for the Study of Bioethical
Issues on that group’s recent report
Moral Science: Protecting Participants
in Human Subjects Research. This will
be followed by a summary of public
comment from OHRP on the ANPRM
Human Subjects Research Protections:
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 77, No. 27 / Thursday, February 9, 2012 / Notices
Enhancing Protections for Research
Subjects and Reducing Burden, Delay
and Ambiguity for Investigators. The
afternoon will also include a
presentation from the Subpart A
Subcommittee (SAS) to inform SACHRP
of recent work. SAS is charged with
developing recommendations for
consideration by SACHRP regarding the
application of subpart A of 45 CFR part
46 in the current research environment;
this subcommittee was established by
SACHRP in October 2006.
On February 29, SACHRP will hear
recommendations from the
Subcommittee on Harmonization (SOH).
SOH was established by SACHRP at its
July 2009 meeting, and is charged with
identifying and prioritizing areas in
which regulations and/or guidelines for
human subjects research adopted by
various agencies or offices within HHS
would benefit from harmonization,
consistency, clarity, simplification and/
or coordination. Following the SOH
report, SACHRP will hear a discussion
on the IRB use of component analysis,
utilizing speakers from the FDA and
academia.
Public Comment will be heard on
both days.
Public attendance at the meeting is
limited to space available. Individuals
who plan to attend the meeting and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the designated contact persons.
Members of the public will have the
opportunity to provide comments on
both days of the meeting. Public
comment will be limited to five minutes
per speaker. Any members of the public
who wish to have printed materials
distributed to SACHRP members for this
scheduled meeting should submit
materials to the Executive Director,
SACHRP, prior to the close of business
February 23, 2012.
Dated: February 3, 2012.
Jerry Menikoff,
Director, Office for Human Research
Protections, Executive Secretary, Secretary’s
Advisory Committee on Human Research
Protections.
[FR Doc. 2012–2958 Filed 2–8–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substances and
Disease Registry
[ATSDR–273]
Notice of Development of Set 25
Toxicological Profiles
Agency for Toxic Substances
and Disease Registry (ATSDR),
Department of Health and Human
Services (DHHS).
ACTION: Notice.
AGENCY:
This notice announces the
development of Set 25 Toxicological
Profiles, which will consist of four
updated profiles. ATSDR will make
these profiles available to the public on
or about October 17, 2012 and will
solicit public comments at that time for
a 90-day period. Electronic access to
these documents will be available at the
ATSDR Web site: https://www.atsdr.cdc.
gov/toxprofiles/index.asp.
SUMMARY:
Set 25 Toxicological Profiles
The following toxicological profiles
are now being developed:
Name
1 ...........................................
2 ...........................................
3 ...........................................
4 ...........................................
Hexachlorobenzene (UPDATE) ........................................................................................................
Endosulfan (UPDATE) ......................................................................................................................
Endosulfan sulfate .....................................................................................................................
Endosulfan-alpha .......................................................................................................................
Endosulfan-beta .........................................................................................................................
1,1-Dichloroethane (UPDATE) ..........................................................................................................
Dinitrotoluenes (DNT) (UPDATE):
2,3-DNT .....................................................................................................................................
2,4-DNT .....................................................................................................................................
2,5-DNT .....................................................................................................................................
2,6-DNT .....................................................................................................................................
3,4-DNT .....................................................................................................................................
3,5-DNT .....................................................................................................................................
The
Superfund Amendments and
Reauthorization Act of 1986 (SARA) (42
U.S.C. 9601 et seq.) amended the
Comprehensive Environmental
Response, Compensation, and Liability
Act of 1980 (CERCLA or Superfund) (42
U.S.C. 9601 et seq.) by establishing
certain requirements for ATSDR and the
U.S. Environmental Protection Agency
(EPA) with regard to hazardous
substances that are most commonly
found at facilities on the CERCLA
National Priorities List (NPL). Among
these statutory requirements is a
mandate for the Administrator of
ATSDR to prepare toxicological profiles
for each substance included on the
Priority List of Hazardous Substances
(www.atsdr.cdc.gov/SPL). This list
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names 275 hazardous substances that
pose the most significant potential
threat to human health as determined by
ATSDR and EPA. The availability of the
revised list of the 275 priority
substances was announced in the
Federal Register on November 3, 2011
(76 FR 68193). For prior versions of the
list of substances, see Federal Register
notices dated April 17, 1987 (52 FR
12866); October 20, 1988 (53 FR 41280);
October 26, 1989 (54 FR 43619); October
17, 1990 (55 FR 42067); October 17,
1991 (56 FR 52166); October 28, 1992
(57 FR 48801); February 28, 1994 (59 FR
9486); April 29, 1996 (61 FR 18744;
November 17, 1997 (62 FR 61332);
October 21, 1999 (64 FR 56792); October
25, 2001 (66 FR 54014); November 7,
2003 (68 FR 63098); December 7, 2005
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115–29–7
1031–07–8
95–99–98
33213–65–9
75–34–3
602–01–7
121–14–2
619–15–8
606–20–2
610–39–9
618–85–9
(70 FR 70284); and March 6, 2008 (73
FR 12178).
Notice of the availability of drafts of
these four updated toxicological profiles
for public review and comment will be
published in the Federal Register on or
about October 17, 2012, with notice of
a 90-day public comment period for
each profile, starting from the actual
release date. Following the close of the
comment period, chemical-specific
comments will be addressed, and,
where appropriate, changes will be
incorporated into each profile.
FOR FURTHER INFORMATION CONTACT:
Commander Jessilynn B. Taylor,
Division of Toxicology and
Environmental Medicine, Agency for
Toxic Substances and Disease Registry,
1600 Clifton Road NE., Mail Stop F–62,
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[Federal Register Volume 77, Number 27 (Thursday, February 9, 2012)]
[Notices]
[Pages 6799-6800]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-2958]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Secretary's Advisory Committee on Human Research
Protections
AGENCY: Department of Health and Human Services, Office of the
Secretary, Office of the Assistant Secretary for Health.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Pursuant to Section 10(a) of the Federal Advisory Committee
Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's
Advisory Committee on Human Research Protections (SACHRP) will hold its
twenty-seventh meeting. The meeting will be open to the public.
Information about SACHRP and the meeting agenda will be posted on the
SACHRP Web site at: https://www.dhhs.gov/ohrp/sachrp/mtgings/.
DATES: The meeting will be held on Tuesday, February 28, 2012 from 8:30
a.m. until 5 p.m. and Wednesday, February 29, 2012 from 8:30 a.m. until
5:00 pm.
ADDRESSES: U.S. Department of Health & Human Services, 200 Independence
Avenue SW., Hubert H. Humphrey Building, Room 705, Washington, DC
20201.
FOR FURTHER INFORMATION CONTACT: Jerry Menikoff, M.D., J.D., Director,
Office for Human Research Protections (OHRP), or Julia Gorey, J.D.,
Executive Director, SACHRP; U.S. Department of Health and Human
Services, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852;
240-453-8141; fax: 240-453-6909; email address: Julia.Gorey@hhs.gov.
SUPPLEMENTARY INFORMATION: Under the authority of 42 U.S.C. 217a,
Section 222 of the Public Health Service Act, as amended, SACHRP was
established to provide expert advice and recommendations to the
Secretary of Health and Human Services and the Assistant Secretary for
Health on issues and topics pertaining to or associated with the
protection of human research subjects.
The meeting will open February 28 with remarks from SACHRP Chair
Dr. Barbara Bierer and OHRP Director Dr. Jerry Menikoff, followed by a
summary report from the Presidential Commission for the Study of
Bioethical Issues on that group's recent report Moral Science:
Protecting Participants in Human Subjects Research. This will be
followed by a summary of public comment from OHRP on the ANPRM Human
Subjects Research Protections:
[[Page 6800]]
Enhancing Protections for Research Subjects and Reducing Burden, Delay
and Ambiguity for Investigators. The afternoon will also include a
presentation from the Subpart A Subcommittee (SAS) to inform SACHRP of
recent work. SAS is charged with developing recommendations for
consideration by SACHRP regarding the application of subpart A of 45
CFR part 46 in the current research environment; this subcommittee was
established by SACHRP in October 2006.
On February 29, SACHRP will hear recommendations from the
Subcommittee on Harmonization (SOH). SOH was established by SACHRP at
its July 2009 meeting, and is charged with identifying and prioritizing
areas in which regulations and/or guidelines for human subjects
research adopted by various agencies or offices within HHS would
benefit from harmonization, consistency, clarity, simplification and/or
coordination. Following the SOH report, SACHRP will hear a discussion
on the IRB use of component analysis, utilizing speakers from the FDA
and academia.
Public Comment will be heard on both days.
Public attendance at the meeting is limited to space available.
Individuals who plan to attend the meeting and need special assistance,
such as sign language interpretation or other reasonable
accommodations, should notify the designated contact persons. Members
of the public will have the opportunity to provide comments on both
days of the meeting. Public comment will be limited to five minutes per
speaker. Any members of the public who wish to have printed materials
distributed to SACHRP members for this scheduled meeting should submit
materials to the Executive Director, SACHRP, prior to the close of
business February 23, 2012.
Dated: February 3, 2012.
Jerry Menikoff,
Director, Office for Human Research Protections, Executive Secretary,
Secretary's Advisory Committee on Human Research Protections.
[FR Doc. 2012-2958 Filed 2-8-12; 8:45 am]
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